Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?

NCT ID: NCT04349176

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-12
• Study Completion Date: 2022-12-31

Brief Summary

The study will enroll patients through the Neurology Department at Naval Medical Center San Diego (NMCSD). Eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. Participants with comorbidities and medication regimens commonly exhibited within real-world DOD medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period.

This will comprise "Group A". A carefully screened group will comprise "Group B" and meet exclusion criteria designed to approximate that of the PREEMPT2 trial. Within each group, half of the patients (155U Arm) will be randomly selected to receive the standard 155U over 31 fixed sites every 12 weeks while the other half (100U Arm) will receive 100U over 19 fixed sites every 12 weeks. Minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.

Conditions

Chronic Migraine, Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A 100U

Group Type: EXPERIMENTAL

Dose

Intervention Type: DRUG

Randomized to either 100U or 155U

Group A 155U

Group Type: EXPERIMENTAL

Dose

Intervention Type: DRUG

Randomized to either 100U or 155U

Group B 100U

Group Type: EXPERIMENTAL

Dose

Intervention Type: DRUG

Randomized to either 100U or 155U

Group B 155

Group Type: EXPERIMENTAL

Dose

Intervention Type: DRUG

Randomized to either 100U or 155U

Interventions

Dose

Randomized to either 100U or 155U

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Chronic migraine headache - Diagnostic criteria:

A. Headache (tension-type-like and/or migraine-like) on 15 days per month for >3 months2 and fulfilling criteria B and C B. Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura

C. On 8 days per month for >3 months, fulfilling any of the following 3 :

1. criteria C and D for 1.1 Migraine without aura

2. criteria B and C for 1.2 Migraine with aura

3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D. Not better accounted for by another ICHD-3 diagnosis. -

Exclusion Criteria

Previous exposure at any time to any botulinum toxin serotype Pregnancy, breastfeeding or plans to become pregnant within 6 months Age <18 years Failure to complete at least 20 days of headache diary in the 28 day baseline period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Sarah Hodges, DO

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2016.0039

Identifier Type: -

Identifier Source: org_study_id